Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients

Inclusion Criteria

• Male and female patients aged 18-75 years old.
• Diagnosis of new coronavirus infection COVID-19 based on medical examination: axillary temperature >37.5°C, upper respiratory infection symptoms, SpO2 ≥ 95%, no symptoms of moderate or severe forms.
• The minimal baseline score for COVID-19-related symptoms defined as follows: at least two symptoms with a score of 2 or higher, with the exception of taste and smell where subjects may have a score of 1 or higher, and the absence of shortness of breath (difficulty breathing).
• Positive rapid test for for SARS-CoV-2 (COVID-19).
• The first 24 hours from the disease onset.
• Patients giving their consent to use reliable contraception during the study.
• Signed patient information sheet (informed consent form).

Exclusion Criteria

• Moderate and severe COVID-19.
• The first four weeks after any vaccination/revaccination, including against COVID-19, influenza, pneumococcal and other infections.
• Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.).
• Patients requiring medications prohibited within the study.
• Medical history or previously diagnosed primary and secondary immunodeficiency.
• Medical history/suspicion of oncology of any localization (except for benign neoplasms).
• Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical study.
• Malabsorption syndrome, including congenital or acquired lactase or disaccharidase deficiency, galactosemia.
• Allergy/ hypersensitivity to any of the components of the medications used in the treatment.
• Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
• Use of medications listed in "Prohibited concomitant therapy" within 4 weeks before the study entry.
• Patients who, from the investigator's point of view, will fail to comply with the requirements of the trial or with the intake regimen of the study drugs.
• Medical history of mental diseases, alcoholism or drug abuse which, according to the investigator's opinion, will interfere with the study procedures.
• Participation in other clinical trials within 3 months prior to enrollment in this study.
• The patient is related to the study center staff directly involved in the trial or is the immediate relative of the investigator. Immediate family is defined as a spouse, parents, children or siblings, whether natural or adopted.
• The patient works for OOO "NPF "MATERIA MEDICA HOLDING" i.e. is the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family.